Skip to main content
Clinical Trials/NCT01513408
NCT01513408
Active, not recruiting
Not Applicable

Prospective Study of the Relevance of T Lymphocytes Tumor Infiltrates CD8 and Foxp3 as a New imMUne Prognostic Biomarker in Breast Cancer Treated by NEOadjuvant Chemotherapy

Centre Georges Francois Leclerc1 site in 1 country500 target enrollmentMay 2012
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Centre Georges Francois Leclerc
Enrollment
500
Locations
1
Primary Endpoint
Overall survival
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

Neoadjuvant chemotherapy is standard therapy for the management of localised breast cancer, and makes it possible to evaluate tumour response. Achieving pathological complete response (pCR) after chemotherapy is the most important prognostic factor for these patients. However, patients with pCR can suffer relapse. In parallel, long-term prognosis of patients who do not achieve pCR is poorly documented, and no specific prognostic factors have been clearly identified.Preclinical and clinical studies argue for an immunogenic role of some chemotherapy regimens, such as anthracyclines, taxanes or trastuzumab. By facilitating recruitment of CD8 T-lymphocytes in the tumour bed, these agents could favourably influence antitumour immune response, partially contributing to efficacy. Conversely, tumours can promote accumulation of regulatory T-lymphocytes expressing Foxp3, thus evading anti-tumour immune response, and increased numbers of regulatory T-cells are associated with less favourable prognosis in breast cancer patients. We have previously shown that a high number of CD8 T-cells associated with low Foxp3 infiltration, as quantified by immunohistochemistry on surgical specimens, is associated with better response and better survival in breast cancer patients, independently of whether pCR was achieved, the type of chemotherapy used, and the type of breast cancer. Therefore, we propose to validate in a prospective study this immunological prognostic marker in a large cohort of patients treated with neoadjuvant chemotherapy.

Registry
clinicaltrials.gov
Start Date
May 2012
End Date
October 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Overall survival

Time Frame: From date of inclusion up to the end of follow-up period : december 2014 (anticipated)

Overall survival is defined as the time from inclusion date to death from any cause, or to date of last follow-up, if death does not occur.

Secondary Outcomes

  • Pathological complete response(After surgery)
  • Recurrence-free survival(From inclusion up to the end of follow up period: december 2014)
  • PathIm score (pathological-immunological)(From inclusion up to the end of surgery for all patients: december 2014 (anticipated))

Study Sites (1)

Loading locations...

Similar Trials